Financial Data and Key Metrics Changes - Seres reported a net loss from continuing operations of 15.7millionforQ42024,comparedtoanetlossof34.7 million for the same period in 2023, indicating a significant improvement [49] - For the full year 2024, the net loss from continuing operations was 125.8million,downfrom190.1 million in 2023, primarily due to lower operating expenses of approximately 74 million [49] - Research and development (R&D) expenses for Q4 2024 were 12.8 million, down from 23 million in Q4 2023, and for the full year, R&D expenses were 64.6 million compared to 117.6 million in 2023 [51] - General and administrative (G&A) expenses for Q4 2024 were 12.5 million, down from 14 million in Q4 2023, and for the full year, G&A expenses were 53.2 million compared to 77.5millionin2023[52]BusinessLineDataandKeyMetricsChanges−ThecompanyhasmadesubstantialprogressinadvancingitsleadprogramSER−155,whichaimstopreventbloodstreaminfectionsinallo−HSCTrecipients[8][12]−SER−155showedaclinicallymeaningful77155 million at closing [46][47] - The cash position as of December 31, 2024, was $30.8 million, with expectations to fund operations into the first quarter of 2026 [55] Q&A Session Summary Question: Feedback from the FDA regarding manufacturing and patient enrollment - Management indicated that they received comprehensive feedback from the FDA and are in the process of refining the clinical study protocol [67][70] - The population for the next study is considered appropriate, with plans to manage variability through stratification [72] Question: Recent FDA feedback relative to expectations and Phase 2/3 study differences - Management found the FDA feedback constructive and believes more data is needed for the next study [80][84] - A Phase 2/3 study would require pre-specification and locking of certain items, which could take more time [83] Question: Safety database considerations based on VOWST experience - Management noted that the FDA has a minimum threshold of 300 patients for safety data, but discussions will evolve as more data is generated [92] Question: Potential size of the next study and additional efficacy endpoints - Management indicated that a standalone Phase 2 could provide meaningful data quickly, with various endpoints being considered, including GvHD rates [100][102]